Proton Pump Inhibitor Adverse ReactionNCT05815550
Delirium Related to Proton Pump Inhibitors Use
An observational study of Proton Pump Inhibitor Adverse Reaction and Delirium, run by University Hospital, Caen at 1 site in France.
Trial summary
Delirium is a frequent and severe condition, especially in old adults. Its occurrence is due to a drug in 30% of cases. In 2009, the French national health authority (Haute Autorité de Santé) mentioned proton pump inhibitors (PPIs) among the drugs causing delirium. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proton Pump Inhibitor Adverse Reaction, Delirium, Hyponatremia
- What is being tested?
- PPI
- How many people
- 19,081 participants
- Where
- 1 siteFrance
- Study dates
- 9 Feb 2022to 10 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators describe the profile of patients who are reported in the WORLD HEALTH ORGANIZATION Vigibase pharmacovigilance database, as having experienced a delirium. In particular, the number of patients who use proton pomp inhibitors (PPIs), the number of patients who presented associated illnesses known to induce delirium, the number of patients who presented associated drug prescriptions known to induce delirium.
Who may be able to join
- PPI use
- Delirium mentioned in the safety report
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Delirium and Use of Proton Pump Inhibitors: Analysis of the Global Pharmacovigilance Database
Delirium is a frequent and severe condition, especially in old adults. Its occurrence is due to a drug in 30% of cases. In 2009, the French national health authority (Haute Autorité de Santé) mentioned proton pump inhibitors (PPIs) among the drugs causing delirium. Most reports of delirium associated with PPI use in the literature are due to severe hyponatremia due to syndrome of inappropriate antidiuretic hormone secretion. However, a few case reports have described the occurrence of delirium PPI without hyponatremia related to PPI use. In 2016, a prospective observational study including 675 old adults found an association between PPI use and the occurrence of delirium.
Evidence linking delirium and PPI use is thus scarce. By using data from the pharmacovigilance database of the World Health Organization (WHO), the investigators aim to describe the characteristics of delirium reports in which PPI were suspected to be involved, and to evaluate the association between PPI use and delirium, and the impact of hyponatremia in this association by performing a disproportionality analysis.
- Being tested
- PPI
- Keywords
- Proton Pump Inhibitor, Delirium, Drug safety, Hyponatremia
- Medical subject headings
- Delirium, Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPIDrug
Use of PPI defined as PPI mentioned in the safety report
| Study group | Role | What they receive |
|---|---|---|
| PPI users | Not described Receives: Drug: PPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium occuring when using PPI
Measured: 09/02/2022
Secondary outcomes (2)
Association between PPI use and occurrence of delirium
Association assessed by performing a disproportionality analysis with adjustment on confounders
Measured: 09/02/2022
Association between PPI use and occurrence of delirium and hyponatremia
Association assessed by performing a disproportionality analysis with adjustment on confounders
Measured: 09/02/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start9 Feb 2022
- Primary completion10 Feb 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Proton Pump Inhibitor Adverse ReactionStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 19,081 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815550
- Sponsor's protocol ID
- 2646
- Status last verified
- Apr 2023
- First submitted
- 4 Apr 2023
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Decros A, Minoc EM, Lelong-Boulouard V, Chretien B, Meurant A, Alexandre J, Dolladille C, Villain C. Association between exposure to proton pump inhibitors and delirium: a descriptive and disproportionality analysis of VigiBase. BMJ Open. 2024 Oct 16;14(10):e081911. doi: 10.1136/bmjopen-2023-081911.
PubMed 39414279
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Delirium and Use of Proton Pump Inhibitors: Analysis of the Global Pharmacovigilance Database
- ClinicalTrials.gov ID
- NCT05815550
- Acronym / sponsor ID
- 2646
- Keywords
- Proton Pump Inhibitor, Delirium, Drug safety, Hyponatremia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19,081 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Delirium is a frequent and severe condition, especially in old adults. Its occurrence is due to a drug in 30% of cases. In 2009, the French national health authority (Haute Autorité de Santé) mentioned proton pump inhibitors (PPIs) among the drugs causing delirium. Most reports of delirium associated with PPI use in the literature are due to severe hyponatremia due to syndrome of inappropriate antidiuretic hormone secretion. However, a few case reports have described the occurrence of delirium PPI without hyponatremia related to PPI use. In 2016, a prospective observational study including 675 old adults found an association between PPI use and the occurrence of delirium.
Evidence linking delirium and PPI use is thus scarce. By using data from the pharmacovigilance database of the World Health Organization (WHO), the investigators aim to describe the characteristics of delirium reports in which PPI were suspected to be involved, and to evaluate the association between PPI use and delirium, and the impact of hyponatremia in this association by performing a disproportionality analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PPI users | – | Drug: PPI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators describe the profile of patients who are reported in the WORLD HEALTH ORGANIZATION Vigibase pharmacovigilance database, as having experienced a delirium. In particular, the number of patients who use proton pomp inhibitors (PPIs), the number of patients who presented associated illnesses known to induce delirium, the number of patients who presented associated drug prescriptions known to induce delirium.
Key inclusion criteria (2 listed)
- PPI use
- Delirium mentioned in the safety report
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPIUse of PPI defined as PPI mentioned in the safety report | Drug | PPI users |
Primary outcome
Delirium occuring when using PPI
Time frame: 09/02/2022
2 secondary outcomes
Association between PPI use and occurrence of delirium
Time frame: 09/02/2022
Association between PPI use and occurrence of delirium and hyponatremia
Time frame: 09/02/2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Derived from this study: PubMed 39414279Decros A, Minoc EM, Lelong-Boulouard V, Chretien B, Meurant A, Alexandre J, Dolladille C, Villain C. Association between exposure to proton pump inhibitors and delirium: a descriptive and disproportionality analysis of VigiBase. BMJ Open. 2024 Oct 16;14(10):e081911. doi: 10.1136/bmjopen-2023-081911.
- Individual participant dataSharing planned: Undecided
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proton Pump Inhibitor Adverse Reaction and Delirium, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium occuring when using PPI (time frame: 09/02/2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05815550, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.